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Could a simple pill shield HAE patients from Procedure-Triggered attacks?

NCT ID NCT07654829

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This trial tests whether the drug sebetralstat can prevent swelling attacks in people with hereditary angioedema (HAE) when taken before a medical procedure. Participants aged 12 and older with HAE type I or II will take sebetralstat just before their scheduled procedure. The main goal is to see if the drug prevents an HAE attack within 24 hours after the procedure starts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sebetralstat (KVD900)
What this could lead to
If effective, sebetralstat could offer a simple pill to prevent dangerous swelling attacks triggered by medical procedures.
What could go wrong
This is an open-label trial without a placebo, so results may be less reliable. The drug may not prevent all attacks, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female patients ≥12 years of age at time of Screening 2. Confirmed diagnosis of HAE Type I or II based on patient report 3. Patient has a qualifying procedure that is scheduled or planned to be scheduled to occur within 8 weeks of Screening 4. Patient has access to a commercial available on-demand treatment for HAE 5. Female patients of childbearing potential, including post-menarchal adolescents, must meet contraception requirements per Section 11.3. (Note: male patients do not require contraception) 6. Patients must be able to swallow trial tablets whole 7. Patients, as assessed by the Investigator, must be able to appropriately receive and store IMP, and be able to read, understand, and complete the questionnaire 8. Investigator believes that the patient is willing and able to adhere to all protocol requirements through the duration of the trial 9. Patient provides informed consent or assent (when applicable). A parent or legally authorized representative (LAR) must also provide signed informed consent when required Exclusion Criteria: 1. A clinically significant history of poor response to bradykinin receptor 2 blocker, C1-INH therapy, or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator 2. Use of angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Screening Visit 3. Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit 4. Patients who are taking strong cytochrome P450 (CYP)3A4 inhibitors or inducers or moderate CYP3A4 inducers within 2 weeks of the procedure 5. Any clinically significant comorbidity or systemic dysfunction, which in the opinion of the Investigator, would jeopardize the safety of the patient by participating in the trial 6. History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator 7. Known hypersensitivity to sebetralstat or to any of the excipients 8. Participation in any gene therapy treatment or trial for HAE 9. Any pregnant or breastfeeding patient

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • KalVista Investigative Site

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

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